Job Description
Support and lead the development of medical device products, including writing or verifying specifications; maintaining product process; designing fixtures; and testing processes, equipment, and raw materials to ensure the concepts and/or prototypes meet their requirements. Job duties:
- Develop new product concepts and products by applying various engineering disciplines, such as mechanical, electrical, materials, bioengineering, or other relevant fields2. Provide engineering design and process development, and/or sustain engineering support.
- Develop products or processes, or the capabilities to support them, such as test methods, equipment/fixtures, data engineering, statistics, software coding and application, engineering/business intelligence, or various analytical methods, etc.
- Generate intellectual property; write invention disclosures.
- Specify and/or direct the specification and testing of new materials and designs.
- Confer with appropriate departments, resources, and/or outside services to prepare design modifications, clarify problems, and develop designs.
- Support projects through regulatory submissions and approvals.
- Largely self-directed and capable of meeting project goals with minimal supervision.
- Lead projects and mentor Assemblers, Technicians, and others as needed.
- Lead all activities relating to test method development, data analysis, root cause investigations, and formal test report release.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
Qualifications
- Bachelor’s degree in mechanical engineering, Industrial Engineering, or Materials Science Engineering.
- Minimum of ten (10) years of relevant work experience in medical device industry.
- Strong written and verbal communication skills.
- Ability to design and develop medical devices.
- Ability to read and prepare technical documentation.
- Possess working knowledge of medical device manufacturing equipment/processes.
- Knowledge of medical and technical development.
- Expert proficiency with MS Word, Excel, PowerPoint, Minitab, SolidWorks and/or other CAD systems.
Desired Qualifications
- Advanced degree in Mechanical Engineering, Industrial Engineering, or Materials Science Engineering.
- Ability to effectively manage internal and external customer relationships as well as leading different key players on achieving a goal.
- Ability to work closely and effectively with multiple departments and associates.
- Ability to prioritize and meet deadlines in a timely manner.
